Prediction of Post-induction Hypotension with Arterial Pulse wave applied Machine Learning, a non-randomized prospective data collection observational study.

Recruiting

• Conditions: Hemodynamiek, intra-operatief; hypotension; low blood pressure

• Registration Number: NL-OMON52930
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1200

Inclusion Criteria

Elective surgical patients:
- >=18 years of age
- Informed consent
- Planned for any type of elective surgery

Intensive Care Unit patients requiring intubation:
- >= 18 years of age
- Informed consent or deferred consent
- Requiring (emergency) intubation

Intensive Care Unit patients requiring elective tracheostomy:
- >= 18 years of age
- Informed consent or deferred consent
- Requiring elective tracheostomy

Exclusion Criteria

Elective surgical patients:
- Any right-sided structural pathology or reduced cardiac function (Tapse
<1.5cm) (only phase 2)
- Severe cardiac arrhythmias (with high heart rate), including atrial
fibrillation
- Abnormal anatomy of the fingers
- Emergency surgery (only phase 2)
- Allergy for medication used in study protocol
- Subjects will be excluded if both noninvasive blood pressure (with the finger
cuff) and invasive blood pressure (with an arterial cannula already available
due to standard of care) cannot be measured according to the Instructions for
Use of the CS/EV1000/HemoSphere system.

Intensive Care Unit patients requiring intubation:
- Subjects will be excluded if both noninvasive blood pressure (with the finger
cuff) and invasive blood pressure (with an arterial cannula already available
due to standard of care) cannot be measured according to the Instructions for
Use of the CS/EV1000/HemoSphere system.

Intensive Care Unit patients requiring elective tracheostomy:
- Subjects will be excluded if both noninvasive blood pressure (with the finger
cuff) and invasive blood pressure (with an arterial cannula already available
due to standard of care) cannot be measured according to the Instructions for
Use of the CS/EV1000/HemoSphere system.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified